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July 24, 2001

Insulin Analogs

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Question from Phoenix, Arizona, USA:

My three and a half year old daughter who has had type 1 diabetes for two years, was recently put on Lantus, and I read that Lantus is only FDA approved for children over the age of six. Is Lantus safe for my daughter? Are all insulins only approved for children over the age of six? Is Lantus safer for young children than an insulin pump?

Answer:

From: DTeam Staff

Your questions are good ones.”FDA approval” limited to children greater than six really means that it was not tested in younger kiddies with type 1 diabetes. That is not to say that it is explicitly dangerous nor forbidden to use in younger children. It hasn’t undergone wide testing to address questions such as: Is it effective? Is it safe? Is it better (than another regimen of insulin such as Ultralente or even a pump)? Of course, insulin pumps aren’t “approved” for use in younger children either.

However, there is no compelling reason not to prescribe them, and the risk is we don’t know long term outcomes. (Some folks argue that doctors and pump manufacturers are taking a large risk in prescribing them for younger children with diabetes on the chance that a severe pump malfunction occurs and/or hypoglycemia occurs.) True, some people prescribe “the newest” because it is novel and new. Why was the recommendation given to start Lantus (insulin glargine)?

My advice is to talk with your daughter’s diabetes specialist about your trepidations of glargine (Lantus) and see if the explanation allays the concerns and that the rationale for its use makes sense to you and your daughter’s situation. There are possible alternatives, but perhaps you have tried them.

DS